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Efficacy of heel lifts versus calf muscle eccentric exercise for mid-portion Achilles tendinopathy (the HEALTHY trial): study protocol for a randomised trial.

ABSTRACT: Background:Mid-portion Achilles tendinopathy is a common musculoskeletal condition characterised by degeneration of the Achilles tendon, which causes pain and disability. Multiple non-surgical treatments have been advocated for this condition including calf muscle eccentric exercise and in-shoe heel lifts. Although adherence is challenging, there is evidence to suggest that calf muscle eccentric exercise is effective in decreasing pain and improving function in people with Achilles tendinopathy. Heel lifts reduce ankle joint dorsiflexion and Achilles tendon strain, however their efficacy in the management of Achilles tendinopathy is unclear. This article describes the design of a parallel-group randomised trial comparing the efficacy of heel lifts to calf muscle eccentric exercise for Achilles tendinopathy. Methods:Ninety-two participants with Achilles tendinopathy will be randomised to one of two groups: (i) a heel lift group that will receive pre-fabricated 12?mm in-shoe heel lifts (Clearly Adjustable®), or (ii) an exercise group that will be advised to carry out a calf muscle eccentric exercise program (twice a day, 7?days a week, for 12?weeks). Outcome measures will be obtained at baseline, 2, 6 and 12?weeks; the primary endpoint for assessing efficacy being 12?weeks. The primary outcome measure will be the total score of the Victorian Institute of Sport Assessment - Achilles (VISA-A) questionnaire. Secondary outcome measures will include thickness and integrity of the Achilles tendon (using ultrasound tissue characterisation [UTC]), participant perception of treatment effect on pain and function (using the 7-point Patient Global Impression of Change scale), severity of pain at the Achilles tendon (using a 100?mm visual analogue scale) in the previous week, health status (using the EuroQol-5D-5L™ questionnaire), physical activity levels (using the 7-day Recall Physical Activity Questionnaire) and calf muscle function (using the standing heel rise test). Data will be analysed using the intention to treat principle. Discussion:The HEALTHY trial (Heel lifts versus calf muscle eccentric Exercise for AchiLles TendinopatHY) is the first randomised trial to compare the efficacy of heel lifts to calf muscle eccentric exercise in reducing pain and improving function in people with Achilles tendinopathy. A pragmatically designed trial was developed to ensure that if the interventions are found to be effective, the findings can be readily implemented in clinical practice. Trial registration:Australian New Zealand Clinical Trials Registry: ACTRN12617001225303. Registered on August 22nd, 2017.

SUBMITTER: Rabusin CL

PROVIDER: S-EPMC6429802 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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Efficacy of heel lifts versus calf muscle eccentric exercise for mid-portion Achilles tendinopathy (the HEALTHY trial): study protocol for a randomised trial.

Rabusin Chantel L CL Menz Hylton B HB McClelland Jodie A JA Evans Angela M AM Landorf Karl B KB Malliaras Peter P Docking Sean I SI Munteanu Shannon E SE

Journal of foot and ankle research 20190321

<h4>Background</h4>Mid-portion Achilles tendinopathy is a common musculoskeletal condition characterised by degeneration of the Achilles tendon, which causes pain and disability. Multiple non-surgical treatments have been advocated for this condition including calf muscle eccentric exercise and in-shoe heel lifts. Although adherence is challenging, there is evidence to suggest that calf muscle eccentric exercise is effective in decreasing pain and improving function in people with Achilles tendi ...[more]

PMID: 30949243

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Project description:BACKGROUND:Mid-portion Achilles tendinopathy (AT) is prevalent amongst athletic and non-athletic populations with pain, stiffness and impaired function typically reported. While different management options exist, loading protocols remain the best available intervention and have been shown to be effective in the management of AT. Trials investigating loading in AT have used a variety of different protocols, and recent narrative reviews suggest that no protocol is superior to another when comparing outcomes in pain and function. However, there has been no systematic review or meta-analysis completed to determine this. Furthermore, the narrative review did not consider wait-and-see or sham interventions, thus a systematic review and met-analysis which includes wait-and-see or sham interventions is warranted. METHODS:A systematic review and meta-analyses will be conducted as per the PRISMA guidelines. The databases PUBMED, CINAHL (Ovid) and CINAHL (EBSCO) will be searched for articles published from inception to 31 December 2017. Our search focuses on studies examining the improvement of pain and function when completing a loading program for mid-portion AT. Only randomised/ quasi-randomised trials will be included while case reports and case series will be excluded. The primary outcome assessing pain and function will be the Victorian Institute Sports Assessment - Achilles (VISA-A). Two reviewers will screen articles, extract data and assess the risk of bias independently with a third reviewer resolving any disagreements between the two reviewers. A meta-analysis will then be performed on the data (if appropriate) to determine if the traditional heavy load calf training protocol described by Alfredson is superior to wait-and-see, sham intervention, traditional physiotherapy, and other forms of exercise rehabilitation. DISCUSSION:This systematic review and meta-analysis will allow us to investigate if there are difference in pain and function when comparing wait-and-see, sham interventions, traditional physiotherapy and different exercise interventions to the traditional heavy eccentric calf training protocol for mid-portion Achilles tendon pain. SYSTEMATIC REVIEW REGISTRATION:PROSPERO registration number CRD42018084493 .

Project description:BackgroundMid-portion Achilles Tendinopathy (AT) is a common musculoskeletal condition with varying rehabilitation success rates. Despite the prevalence of this condition, a considerable proportion of individuals experience persisting pain and functional deficits. Current treatment approaches bias the biomedical model which emphasises physically treating and loading the tendon. Overall, there is a lack of consideration for the central nervous system that is commonly implicated in chronic injuries. The aim of this pilot study was to explore the feasibility of combining Action Observation Therapy (AOT), a treatment technique which targets central changes and influences motor learning, with eccentric exercises in the treatment of mid-portion AT. AOT involves the observation of movements and is commonly followed by the physical performance of these same movements.MethodologyThis was a double-blinded randomised controlled pilot feasibility study. All participants underwent the 12-week Alfredson eccentric training protocol. The intervention group watched videos of the exercises prior to performing these exercises, whilst the control group watched nature videos before performing the same exercises. Study feasibility was the primary outcome measure, with the Victorian Institute of Sports Assessment- Achilles (VISA-A) selected as the primary clinical outcome measure.ResultsThirty participants were recruited, reflecting a 75% eligibility rate and 100% of eligible participants enrolled in the study. The retention rate at week 12 was 80%. At week six the mean VISA-A score improved by 18.1 (95% CI 10.2-26.0) in the intervention group and 7.7 (95% CI 0.3-14.9) in the control group, and 75% and 33% of participants in the intervention and control group respectively exceeded the minimal clinically important difference (MCID). At week 12 the mean VISA-A score from baseline improved by 22.25 (95% CI 12.52-31.98) in the intervention group and 16.5-(95% CI 8.47-24.53) in the control group, equating to 75% and 58% in each group respectively exceeding the MCID.ConclusionThe positive feasibility outcomes and exploratory data from the clinical outcome measures suggest that a larger scaled RCT is warranted to further investigate the impact of AOT in the rehabilitation of mid-portion AT. Trial registration ISRCTN58161116, first registered on the 23/12/2020.

Project description:BackgroundAchilles tendinopathy (AT) is a common overuse injury in running-related sports where patients experience pain and impaired function which can persist. A graded rehabilitation program has been successful in reducing pain and improving function to enable a return to sport. The aim of this study is to compare the effectiveness of a criteria-based rehabilitation program including strength and reactive strength targets, with a previously successful rehabilitation program on changes in pain and function using the Victorian Institute of Sport Assessment-Achilles (VISA-A) questionnaire. Secondary aims will be to assess changes in calf strength, reactive strength, and lower limb running and forward hop biomechanics over the course of a 12-week rehabilitation program, and long-term follow-up investigations.MethodsSixty eligible participants with chronic mid-portion AT who train in running-based sports will be included in this study. They will be randomly assigned to a group that will follow an evidence-based rehabilitation program of daily exercises with progression guided by symptoms or a group performing 3 high-intensity rehabilitation sessions per week with individualised load targets progressing to reactive strength exercises. Testing will take place at baseline, week 6 and 12. Plantar flexor peak torque will be measured using isokinetic dynamometry, reactive strength will be measured using a drop jump and lower limb biomechanical variables will be measured during a single leg forward hurdle hop test and treadmill running using 3D motion analysis. Follow-up interviews will take place at 6, 12 and 24 months after beginning the program which will assess patient participation in sport and possible re-injury.DiscussionThis is the first study to propose an individualised criteria-based graded rehabilitation program in patients in with chronic mid-portion Achilles tendinopathy where progression is guided by strength and reactive strength outcome measures. This study will provide a comprehensive assessment of plantar flexor strength, reactive strength and lower limb biomechanical variables in running and forward hopping with the VISA-A questionnaire as the primary outcome measure and long term post-intervention follow-up assessments performed.Trial registrationClinicalTrials.gov (ID: NCT04384874 ). Registered retrospectively on April 23rd 2020.

Project description:BackgroundExtracorporeal shockwave therapy (ESWT) is used commonly to treat pain and function in Achilles tendinopathy (AT). The aim of this study was to synthesize the evidence from (non-) randomized controlled trials, to determine the clinical effectiveness of ESWT for mid-portion Achilles tendinopathy (mid-AT) and insertional Achilles tendinopathy (ins-AT) separately.MethodsWe searched PubMed/Medline, Embase (Ovid), and Cochrane Central, up to January 2021. Unpublished studies and gray literature were searched in trial registers (ACTRN, ChiCTR, ChiCtr, CTRI, DRKS, EUCTR, IRCT, ISRCTN, JPRN UMIN, ClinicalTrials.gov, NTR, TCTR) and databases (OpenGrey.eu, NARCIS.nl, DART-Europe.org, OATD.org). Randomized controlled trials (RCTs) and non-randomized controlled clinical trials (CCTs) were eligible when investigating the clinical effectiveness of ESWT for chronic mid-AT or chronic ins-AT. We excluded studies that focused on treating individuals with systemic conditions, and studies investigating mixed cohorts of mid-AT and ins-AT, when it was not possible to perform a subgroup analysis for both clinical entities separately. Two reviewers independently performed the study selection, quality assessment, data extraction, and grading of the evidence levels. Discrepancies were resolved through discussion or by consulting a third reviewer when necessary.ResultsWe included three RCTs on mid-AT and four RCTs on ins-AT. For mid-AT, moderate quality of evidence was found for the overall effectiveness of ESWT compared to standard care, with a pooled mean difference (MD) on the VISA-A of 9.08 points (95% CI 6.35-11.81). Subgroup analysis on the effects of ESWT additional to standard care for mid-AT resulted in a pooled MD on the VISA-A of 10.28 points (95% CI 7.43-13.12). For ins-AT, we found very low quality of evidence, indicating that, overall, ESWT has no additional value over standard care, with a standardized mean difference (SMD) of - 0.02 (95% CI - 0.27 to 0.23). Subgroup analysis to determine the effect of ESWT additional to standard care for ins-AT showed a negative effect (SMD - 0.29; 95% CI - 0.56 to - 0.01) compared to standard care alone.ConclusionsThere is moderate evidence supporting the effectiveness of ESWT additional to a tendon loading program in mid-AT. Evidence supporting the effectiveness of ESWT for ins-AT is lacking.Trial registrationPROSPERO Database; No. CRD42021236107.

Project description:BackgroundThere is no consensus regarding the treatment of Achilles insertional tendinopathies. Eccentric training remains the main choice in the conservative treatment of this illness; however, the good results in the management of non-insertional Achilles tendinopathy were not replicated in the insertional condition. Low energy shock wave therapy has been described as an alternative to these patients, but has yet to be empirically tested.HypothesisShock wave therapy, adjunctive to the eccentric strengthening protocol, will improve measures of pain and function.DesignDouble blind, placebo-controlled, parallel groups, randomised clinical trial.Materials and methods93 patients with a diagnosis of chronic insertional tendinopathy, referred from primary or secondary healthcare services, will be assessed and enrolled in this study. They will be divided into two groups (randomised by sequentially numbered identical envelopes, which will be administered serially to participants), one containing the combination of low energy shock wave and eccentric exercises, as treatment and the other comprehending the exercises and the placebo treatment (an apparatus placed in the therapeutic head). The assessments will occur in 2, 4, 6, 12 and 24 weeks. Patients will be evaluated primarily by the Victorian Institute of Sport Assessment-Achilles questionnaire and secondarily by the visual analogue scale, Algometry, the American Orthopedic Foot and Ankle Society scale, the Foot and Ankle Outcome Score and the 12-item Short Form Health Survey. We will use comparison of two proportions via relative frequency analysis, the Pearson Correlation the χ2 test and the analysis of variance for statistical analyses.DiscussionThis study intends to demonstrate if the association of the eccentric exercise programme with the shock wave therapy can produce good results regarding the treatment of the Achilles insertional tendinopathy. In an attempt to prevent the high costs and complications associated with the surgical intervention, we will try to prove this combination as a viable therapeutic option in the conservative management of this prevalent condition. The strengths of the study are the design and the novelty of the combination of methods. The main limitation is the short follow-up course.Ethics and disseminationThe study is registered in the Clinical Trials database (protocol number: 8094833648737701) and was approved by the University Ethics Committee (number: 1373481).Trial registration number8094833648737701 (NCT02757664); Pre-results.

Dataset Information

Efficacy of heel lifts versus calf muscle eccentric exercise for mid-portion Achilles tendinopathy (the HEALTHY trial): study protocol for a randomised trial.

Publications

Efficacy of heel lifts versus calf muscle eccentric exercise for mid-portion Achilles tendinopathy (the HEALTHY trial): study protocol for a randomised trial.

Similar Datasets

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